PREPOPIK Drug Patent Profile

Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Prepopik

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for PREPOPIK

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for PREPOPIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREPOPIK
DailyMed Link:	PREPOPIK at DailyMed

See drug prices for PREPOPIK

See drug sales revenues for PREPOPIK

Recent Clinical Trials for PREPOPIK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Cleveland Clinic	Phase 4
Ferring Pharmaceuticals	Phase 4
Ferring Pharmaceuticals	Phase 3

See all PREPOPIK clinical trials

Paragraph IV (Patent) Challenges for PREPOPIK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREPOPIK	Oral Solution	citric acid; magnesium oxide; sodium picosulfate	10 mg, 3.5 g, and 12 g	202535	1	2014-05-21

US Patents and Regulatory Information for PREPOPIK

PREPOPIK is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,450,338		Y
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,481,083		Y

International Patents for PREPOPIK

When does loss-of-exclusivity occur for PREPOPIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Saudi Arabia

Slovenia

South Africa

South Korea

Spain

Taiwan

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREPOPIK around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5654873
Taiwan	I418352
Russian Federation	2010112483	СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ
Israel	204500	תהליך לייצור הרכב או הרכב רוקחי על ידי ריסוס ציפוי של שכבת נתרן פיקוסולפאט על גרעין של אשלגן ביקרבונאט (Process for the manufacture of a composition or pharmaceutical composition comprising spray coating a layer of sodium picosulphate on a core of potassium bicarbonate)
Mexico	2010003588	PROCESO PARA LA MANUFACTURA DE UN PRODUCTO FARMACEUTICO. (PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT.)
Australia	2008309287
Poland	2207526

Market Dynamics and Financial Trajectory for PREPOPIK

Last updated: August 3, 2025

Introduction

PREPOPIK, a prescription-only bowel preparation product, has carved out a significant niche within the gastroenterology segment. Primarily indicated for colonoscopy preparation, PREPOPIK’s active compound, sodium picosulfate, along with other constituents, facilitates effective bowel cleansing. As gastrointestinal diagnostics gain prominence worldwide, understanding the market dynamics and financial trajectory of PREPOPIK provides valuable insights for stakeholders ranging from healthcare providers to investors.

This analysis delves into the current and projected market landscape, key drivers influencing growth, competitive positioning, regulatory environment, and financial prospects for PREPOPIK over the coming years.

Market Overview and Current Position

PREPOPIK’s market positioning centers on its efficacy, safety profile, and patient convenience. Its three-dose regimen in split dosing enhances tolerability compared to traditional bowel prep products like polyethylene glycol (PEG) solutions. According to reports, the global colonoscopy market was valued at approximately $4.9 billion in 2021 and is projected to expand at a compound annual growth rate (CAGR) of around 6% through 2028 [1].

Within this domain, PREPOPIK holds a competitive edge owing to its rapid onset, minimal volume requirement, and low incidence of adverse events. Its main rivals include PEG-based regimens, sodium phosphate solutions, and other low-volume preps such as MoviPrep and Suprep.

While PREPOPIK was initially launched in select markets—primarily the United States and parts of Europe—its geographic reach has been expanding, with regulatory approvals securing broader access. The product's sales are influenced heavily by physician prescribing behavior, patient acceptance, and reimbursement policies.

Key Market Drivers

1. Increasing Incidence of Gastrointestinal Diseases

Rising prevalence of colorectal cancers, inflammatory bowel disease (IBD), and other GI pathologies drives demand for colonoscopic procedures. The American Cancer Society estimates that annually, over 140,000 new cases of colorectal cancer are diagnosed in the U.S. alone [2]. Preventative screenings and early detection amplify the need for effective bowel preparation agents like PREPOPIK.

2. Growing Adoption of Minimally Invasive Diagnostics

Advancements in endoscopic technology, combined with patient preference for less invasive procedures, foster increased colonoscopy utilization. As healthcare systems shift toward outpatient procedures, options that improve patient compliance—such as PREPOPIK—gain traction.

3. Patient-Centric Formulation Improvements

PREPOPIK’s low-volume and split-dose regimen address common patient complaints regarding traditional bowel preps, such as nausea and discomfort. Improved tolerability fosters better compliance, reducing procedural cancellations and repeat procedures, which indirectly boosts market demand.

4. Expanding Regulatory Approvals

Enhanced regulatory approvals in developed economies facilitate broader utilization. In the U.S., the FDA approved PREPOPIK in 2018, recognizing its safety and efficacy profile. Similar approvals in Europe and Asian markets are expected to further expand its footprint.

5. Reimbursement and Healthcare Policy Dynamics

Insurance coverage and reimbursement parameters significantly influence prescription patterns. As payers recognize the cost-effectiveness of PREPOPIK—potentially reducing procedural delays and complications—its adoption is set to rise.

Challenges and Market Barriers

1. Competitive Pricing and Alternative Agents

Traditional PEG solutions, often low-cost, remain widely used. Moreover, sodium phosphate preps, although associated with safety concerns, are entrenched in some markets due to established familiarity. Price competition may hinder PREPOPIK’s market penetration.

2. Safety Concerns and Contraindications

Though generally well tolerated, PREPOPIK’s contraindications—such as in patients with renal impairment or heart failure—limit its use in certain populations. Vigilant patient screening reduces its applicability relative to more versatile but less tolerable agents.

3. Patent and Regulatory Considerations

Patent expirations or lack of exclusivity in key markets might incite generic competition, leading to price erosion and reduced margins.

Financial Trajectory and Growth Projections

1. Revenue Potential and Market Penetration

Given the global colonoscopy market estimated to grow at a CAGR of 6%, attributable to the increasing burden of GI diseases, PREPOPIK’s revenue prospects are promising. Its adoption is directly correlated with colonoscopy volume growth.

In mature markets like the U.S., where colonoscopy procedures have stabilized at approximately 15 million annually, even a modest penetration rate of 10% for PREPOPIK could generate revenues in the vicinity of hundreds of millions USD.

2. Forecasted Growth Trends

Analysts project that global sales of bowel preparation agents, including PREPOPIK, could surpass $1.2 billion by 2028, assuming an aggregate CAGR of 7% [3]. PREPOPIK’s share is expected to expand as awareness and prescribing habits shift favorably.

3. Impact of Geographic Expansion

Market expansion into emerging economies, driven by rising healthcare infrastructure and awareness, presents significant upside. India and China collectively constitute a large demographic segment with rising colorectal screening programs.

4. Pricing Strategies and Reimbursement

Pricing initiatives and reimbursement policies will determine the revenue trajectory. Competitive pricing combined with favorable insurance coverage can accelerate uptake, whereas premium pricing without reimbursement support could restrict growth.

5. R&D and Line Extension Opportunities

Further innovations—such as improved formulations or combination regimens—may enhance efficacy, safety, and patient compliance, reinforcing PREPOPIK’s market position and revenue streams.

Regulatory and Market Outlook

Regulatory landscapes remain generally supportive in major economies. The efficacy demonstrated in clinical trials, combined with favorable safety profiles, favor continued approvals. However, national healthcare policies emphasizing cost containment may influence pricing strategies.

Moreover, increasing standardization of colorectal cancer screening guidelines will likely favor agents like PREPOPIK, which meet evolving demands for patient-centered care.

Competitive Landscape

PREPOPIK operates amidst a multifaceted competitive environment, with key rivals including:

• PEG-based Solutions: Such as GoLYTELY and MoviPrep; characterized by large-volume requirement but lower cost.
• Sodium Phosphate Preps: Offer rapid bowel cleansing but concern over safety, especially in vulnerable populations.
• Other Low-Volume Preps: Like Suprep and Clenpiq; often positioned as premium options with similar efficacy.

Market differentiation hinges on efficacy, safety, tolerability, and patient preference.

Conclusion

The market dynamics for PREPOPIK are characterized by growth driven primarily by the global rise in GI disease prevalence, advances in minimally invasive diagnostics, and formulation benefits enhancing patient compliance. The financial trajectory indicates substantial upside, especially with expanding geographic approvals, increasing procedural volumes, and favorable reimbursement environments.

However, challenges such as competitive pricing pressures, safety considerations, and market penetration barriers necessitate strategic positioning and ongoing innovation. Firms that effectively leverage these dynamics, supported by robust regulatory strategies and comprehensive market access, will likely realize significant financial gains over the coming decade.

Key Takeaways

• The global colonoscopy market is expanding at a CAGR of approximately 6%, underpinning the growth potential for PREPOPIK.
• Increased prevalence of colorectal cancer and GI diseases boost demand, especially in developed economies.
• Formulation advantages—low volume, split dosing, tolerability—are critical differentiators.
• Geographic expansion into emerging markets presents significant growth opportunities.
• Competitive pressures and safety concerns must be managed through strategic pricing, education, and continued clinical development.

FAQs

1. What is the primary indication for PREPOPIK?
PREPOPIK is indicated for bowel preparation prior to colonoscopy, facilitating clear visualization of the colon.

2. How does PREPOPIK differ from traditional bowel preps?
It offers a low-volume, split-dose regimen with improved tolerability and faster onset compared to traditional PEG-based solutions.

3. What are the main competitive challenges facing PREPOPIK?
Price competition from established low-cost agents, safety contraindications, and patent cliff-related generic competition.

4. Which markets offer the greatest growth opportunities for PREPOPIK?
Emerging economies like India and China, along with expanding approvals in Europe and Asia.

5. How will reimbursement policies affect PREPOPIK’s financial outlook?
Positive reimbursement support can accelerate adoption, whereas restrictive policies may limit growth and revenue potential.

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References

[1] MarketWatch, “Colonoscopy Devices Market,” 2022.
[2] American Cancer Society, “Colorectal Cancer Facts & Figures,” 2022.
[3] Grand View Research, “Bowel Preparation Market Size & Trends,” 2022.